Feature Articles

Published: October 12, 2011
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The Year in IVDs

Reviewing a selection of the advanced new products and technologies that IVD manufacturers developed and launched in 2010-2011.

By: Richard Park

Allegra X-30
Allegra X-30 Series Benchtop Centrifuge by Beckman Coulter

The underlying themes and questions in the IVD industry during the past couple of years have been, How will the global economic downturn affect the industry, and how will IVD manufacturers overcome challenges as a result of the recession? Industry analysts continue to believe that the IVD market will not be stalled by difficult economic conditions. Nonetheless, it remains to be seen how the fallout from the recession will affect the IVD industry. For now, IVD manufacturers have continued to develop and release faster, more accurate, and more-effective diagnostic devices. This article examines some of the key segments of the IVD industry, highlighting new product launches in each area.

Instrumentation and Automation
Beckman Coulter introduced the medium-capacity Allegra X-30 Series Benchtop Centrifuge for general research use and clinical sample preparation. The compact, 18-inch-wide instrument is available individually or packaged with the appropriate rotors and labware to provide high-level performance in a range of applications. Additionally, two new rotors are available in conjunction with the Allegra X-30 instruments: the SX4400, a 1.6-liter swinging-bucket rotor, and the S6096 microplate rotor that accommodates 3 × 2 microplates or 2 × 1 deep-well plates. Beckman Coulter offers the new benchtop centrifuge with its newest swinging-bucket rotor, and 15- and 50-mL conical tube adapters to comprise a cell culture application package. Blood-sample processing and microplate application packages also provide everything needed: centrifuge, rotor, and adapters.
Magellan Biosciences announced the FDA clearance of its Trek Diagnostic Systems-brand Sensititre AIM Automated Inoculation Delivery System for use with all Sensititre dried plates. The small-footprint Sensititre AIM system doses microtitre plates, eliminating both skipped wells and costly repeat tests, to improve laboratory workflow and speed results to clinicians. The Sensititre AIM system’s compact, user-friendly design is ideal for use directly on the benchtop or under a microbiology safety cabinet, providing flexible storage and accessibility and conserving valuable laboratory space. The easy-to-use, icon-driven touchscreen facilitates quick selection of dosing volumes and patterns for simple, intuitive operation. The AIM system has been used in veterinary and pharmaceutical laboratories since its development. This recent FDA clearance expands its availability to U.S. clinical laboratories for IVD use.
Ortho Clinical Diagnostics (OCD) announced the launch of the Vitros 4600 Chemistry System that delivers test results for mid- to high-volume laboratories. The Vitros 4600 system is built on the same core Vitros technologies that provide configurable, expandable automation solutions to streamline and standardize laboratory workflow while enhancing throughput. It offers test results using common technologies across OCD’s continuum of integrated and stand-alone systems. Beginning with dry-slide technology, the Vitros 4600 system leverages OCD’s core technologies that maximize patient result quality and promote ease of use and productivity.
 

cobas 800  modular analyzer
cobas 800 modular analyzer series by Roche Diagnostics

Roche Diagnostics received 510(k) clearance from FDA for the cobas 8000 modular analyzer series, a serum work area solution designed for diagnostic laboratories with a workload of 3–15 million clinical chemistry/immunochemistry tests per year. The cobas 8000 series is the newest member of the Roche cobas modular platform family, which combines clinical chemistry and immunochemistry testing. With a peak throughput of up to 9800 tests per hour and up to 280 reagents onboard, it offers a variety of features to help high-volume labs deliver reliable test results with greater efficiency and throughput. The system also provides extensive modular flexibility so labs can configure tailored solutions to meet their individual needs.
In addition, Roche Diagnostics announced the U.S. introduction of the cobas e 602 analyzer, the latest addition to the cobas 8000 modular analyzer series for diagnostic labs with high-volume workloads. Labs are able to combine this new immunoassay module with two existing clinical chemistry modules to create an integrated platform with 24 system configurations to match their specific testing needs. The cobas e 602 module uses Roche’s patented electrochemiluminescence (ECL) technology and includes more than 50 assays on its initial test menu. It offers a throughput of up to 170 immunoassay tests per hour, and when combined with the existing clinical chemistry modules (cobas c 701 module/cobas c 502 module), ten configurations are available, which offer a throughput of 3670-7970 tests per hour.
Sphere Medical’s IVD-GE02 blood analyzer received 510(k) clearance from FDA. The Sphere Medical device is the first ever multiple-use, microchip-based blood analyzer to achieve 510(k) clearance. The blood analyzer measures glucose, pH, carbon dioxide, oxygen, and potassium ions in patient blood samples with performance equivalent to a standard clinical laboratory analysis, which was demonstrated in clinical trials. The device is based around Sphere Medical’s silicon microchip, which is approximately 4 × 6 mm, and contains an array of microsensors that allow fast, accurate analysis of a panel of analytes simultaneously. Sphere plans to add further analytes to the panel, including hematocrit, lactate, sodium, and ionized calcium, which are currently being developed.
Siemens Healthcare Diagnostics launched the Dimension EXL 200 System for the lower-volume clinical laboratory, the latest addition to the company’s family of Dimension integrated chemistry analyzers. The system features LOCI chemiluminescence technology, allowing low-volume laboratory customers access to fast, sensitive immunoassay testing on an integrated platform. The test menu has more than 90% of the critical methods ordered by physicians, and includes a cardiac stat menu with high-sensitivity troponin I results in 10 minutes. Additionally, the Dimension EXL 200 system features technology new to the Dimension EXL systems, focused on increasing productivity in the laboratory.
In addition, Siemens Healthcare Diagnostics received FDA clearance to market its Immulite 2000 XPi Immunoassay System. The Immulite 2000 XPi system offers the largest automated immunoassay test menus available today and features several hardware and software solutions to enhance productivity and efficiency for medium- to high-volume clinical laboratories. New workflow efficiency and productivity features on the Immulite 2000 XPi system include an auto start feature, which automates daily maintenance, and an automated rack loader, which enables users to load patient samples without pausing the system. Additionally, the Immulite 2000 XPi system delivers Internet-based remote monitoring capabilities and an enhanced user-friendly touchscreen interface.
Thermo Fisher Scientific introduced the Thermo Scientific Indiko, a fully automated, compact, random-access chemistry analyzer that received FDA clearance. Indiko is an easy-to-use, cost-effective system designed for clinical chemistry and specialty testing. The Thermo Scientific Indiko benchtop analyzer is designed for routine clinical chemistry testing in small laboratory settings and specialty testing such as specific proteins, drug-of-abuse testing, and therapeutic drug monitoring, including immunosuppressant drug monitoring (ISD). Bar-coded, ready-to-use Thermo Scientific system reagents provide ease of use and optimized package sizes for low-volume testing needs. A mix of bar-coded primary tubes and sample cups may be used at any time, increasing the flexibility of operation. Patient-oriented testing produces results quickly, thereby enhancing the quality of patient care.
 

i30 Instrument
µTASWako i30 instrument by Wako Diagnostics

Wako Diagnostics received 510(k) clearance from FDA to market the μTASWako i30 instrument with alphafetoprotein L3 (AFP-L3) and des-gamma-carboxy prothrombin (DCP) IVD tests in the United States. TheAFP-L3 and DCP assays are intended as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma. Microfluidics has enabled miniaturization and integration of key analyzer processes for the μTASWako i30: sampling, mixing, separation, and detection on microfluidic chips. The system uses immunochemical and electrophoretic techniques to achieve rapid, accurate, precise and sensitive assay results. As a benchtop automated instrument, the μTASWako i30 is designed for efficiency and ease of use in a clinical chemistry setting. Up to six analytes may be selected per patient sample with the first result reported in nine minutes.

Data and Information Management
With the introduction of iVision Scanware, Orgentec Diagnostika has made it possible to automate the evaluation of immunoblots. The software allows these effective and robust test systems to be objectively assessed and the laboratory test results efficiently stored and archived. By graphically representing test results, the software aids physicians and laboratory personnel in interpreting results and makes it possible to obtain a diagnosis within a few minutes of completing incubation. With its comprehensive archival capability, iVision Scanware facilitates the management of large amounts of data and the detailed documentation of results. Incubated blot strips are recorded and digitized by means of a protocol sheet and commercially available flatbed scanner. The software independently identifies the bands and measures their intensity. Analysis of the immunoblots is computer assisted, and data can be supplemented manually.

Serological tests for infecious diseases by Orgentec Diagnostika
Serological tests for infectious diseases by Orgentec Diagnostika

Qiagen launched ScreenGel software for convenient DNA fragment and RNA analysis with the QIAxcel multicapillary gel electrophoresis systems. The software combines the highest possible flexibility for researchers with the ability for standardized and reproducible operations in routine labs. ScreenGel enables the easy performance, interpretation, and customized documentation of electrophoresis analysis. It facilitates system setup and data analysis with an intuitive user interface for easy navigation. Performance of runs is supported by wizards that guide users step-by-step through the experiment setup. The software supports electronic record requirements specified under 21 CFR part 11, and enables standardized sample processing with process templates that cover the entire workflow as well as secure user management with a variety of access levels.
Roche and Voluntis announced the introduction of CoaguChek Link, an online resource that helps simplify and streamline the process of managing patients on anticoagulation therapy. The Web-based application gives patients who self-test their PT/INR a simple, convenient way to report their test results and gives doctors a single, secure site to access data to monitor and manage more effectively their patients on warfarin therapy. It is available to physicians who prescribe a patient self-testing program through CoaguChek Patient Services (CPS), an independent diagnostic testing facility that provides support services for physicians and their patients. The application is based on the Medpassport platform developed by Voluntis, a healthcare software company specializing in patient relationship management.
Siemens Healthcare Diagnostics introduced enhanced versions of the RapidPoint 400/405 and RapidLab 1200 blood gas analyzers that allow for remote viewing capability with RapidComm Data Management and Connectivity Solution Version 3.0. This feature provides laboratory managers the opportunity to view the actual instrument display from a remote location via the RapidComm system, and initiate responsive measures for all connected analyzers. The RapidPoint 400/405 blood gas analyzer, version 3.6, and the RapidLab 1200 analyzer, version 3.1, feature the expanded ability for remote viewing, providing extensive management capabilities when connected to Siemens RapidComm 3.0 data management solution. Utilizing the RapidComm system, managers can connect live to a particular blood gas analyzer, enabling real-time remote troubleshooting and data access.
Sysmex America announced plans to debut expanded software products for its Sysmex WAM middleware and the Medica EasyCell assistant Automated Cell Imaging Analyzer. Sysmex WAM Select is a streamlined hematology solution for clinical laboratories with the Sysmex X-Series instruments and the Sysmex SP-1000i slidemaker/stainer. This comprehensive hematology decision support management system, which uses the same rules as Sysmex WAM, offers a true autovalidation interface to the LIS. The easy-to-use WAM Select is scheduled for launch in fall 2011 and will be available in Canada and the United States.
 

Thermo Scientific Indiko
Thermo Scientific Indiko by Thermo Fisher Scientific

Thermo Fisher Scientific announced the launch of a new informatics solution to support clinical laboratories serving the emerging fields of translational and personalized medicine. Thermo Scientific Clinical LIMS is a fully functional data and sample management system that is designed to improve the management of laboratory workflow and drive a clinical lab’s processes while enabling bi-directional communica­tion between physicians and the lab. Thermo Scientific Clinical LIMS delivers the end-to-end laboratory data and patient data management functionality needed by scientists and technicians involved in clinical and molecular diagnostics and related research. By bringing together the sample-centric core functionality of a LIMS with the patient-centric compliant functionality of a traditional LIS, Thermo Scientific Clinical LIMS supports the delivery of a streamlined and automated information flow, following the patient from point-of-care to molecular testing and results analysis, diagnosis, and treatment.

Point-of-Care Testing
Abbott announced the U.S. launch of the i-Stat 1 Wireless handheld, an update to the i-Stat 1 point-of-care testing system that is used widely in hospitals, emergency rooms, and physicians’ offices. The i-Stat 1 Wireless can potentially save precious time by allowing caregivers to perform critical tests at the bedside and then transmit test results immediately to the patients’ electronic medical record for physician review. FDA cleared the i-Stat 1 Wireless for marketing in the United States in February, and Abbott Point of Care began shipping the product in June. The i-Stat 1 Wireless is designed to help clinicians streamline and accelerate patient-care workflow by combining a broad menu of tests that are commonly used in critical patient-care situations with real-time, wireless result transmission.

CYFRA 21-1 EIA assay by Fujirebio Diagnostics
CYFRA 21-1 EIA assay by Fujirebio Diagnostics

Chembio Diagnostics filed the first module of its premarket approval (PMA) application to FDA for its DPP HIV 1/2 Screening Assay. Chembio’s DPP HIV 1/2 Screening Assay is a yes/no qualitative rapid test for the detection of antibodies to HIV 1 and 2 in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The test is intended to be used as an aid in the diagnosis of HIV/AIDS in point-of-care settings such as public-health and other clinics, hospital emergency rooms, and physicians’ offices. The DPP HIV 1/2 Screening Assay delivers visual results within approximately 15 minutes, is simple to use, has a shelf life of 24 months, and does not require refrigeration.
Diatron Group received FDA 510(k) approval for its automated clinical chemistry system and will begin commercial operations in the United States. The Pictus 400 is a benchtop instrument that can perform up to 400 tests per hour. The Pictus 400 is designed for use in physician office laboratories, and small to medium-sized hospitals and clinics. Diatron’s Metrolab Division manufactures the Pictus 400, which offers in-demand features for the medical office laboratory diagnostic market.
Microvisk Technologies introduced its handheld devices that monitor the blood clotting status of patients to the U.S. market. The devices branded as CoagMax and CoagLite are a point-of-care test and a home-use test, respectively, that clinicians and patients can use to establish the correct dosage of anti-coagulation medication such as Warfarin, and monitor treatment. The devices are set to undergo clinical trials with 250 patients in three major cardiac centers in Florida starting in October, with product launches scheduled for mid-2012.
Siemens Healthcare Diagnostics announced a new enhanced version of its DCA Vantage Analyzer, a point-of-care (POC) immunoassay analyzer for diabetes management. The system provides enhanced operator management and connectivity capabilities to meet the growing demands in POC testing for improved compliance management and data capture into patient records. The DCA Vantage Analyzer with Version 3.0 software has the capacity to manage a larger number of operators while providing the required security access modes to prevent unauthorized use.
In addition, Siemens Healthcare Diagnostics’ D-dimer assay for the company’s Stratus CS Acute Care Diagnostic System has been cleared by FDA to exclude pulmonary embolism (PE) in conjunction with a non-high clinical pretest probability assessment model in point of care. Currently, this is the only assay available in the United States to achieve this clinical validity for use in the point-of-care setting. The expanded use of the Stratus CS system D-dimer test to exclude quickly PE helps physicians at the point of care to provide a more timely assessment in acute situations. Combining a sensitivity of 97% and an even higher negative predictive value of 98% allows clinicians to have greater confidence.

Immunoassays
Abbott announced CE marking for the Architect 25-OH Vitamin D assay, a diagnostic test to measure levels of vitamin D in blood using Abbott’s Architect automated instrument system. The Architect 25-OH Vitamin D assay is a fully automated immunoassay that can help laboratories manage the expected increase in vitamin D testing volumes. It is intended for the quantitative determination of 25-hydroxy vitamin D in human serum and plasma to aid in the assessment of vitamin D sufficiency. The 25-hydroxy vitamin D test provides an accurate gauge of vitamin D status, and its measurement in patients provides opportunities for preventive and therapeutic interventions.
Abbott also introduced the Plex-ID Biothreat Assay, which is designed to detect and distinguish 17 different biothreat pathogens. This assay enables rapid and accurate detection of potentially dangerous microorganisms that could pose serious threats to human health, food, water and other resources. The Plex-ID Biothreat Assay permits analysis of direct specimens, such as blood, water, food and air filter samples, and provides results in less than eight hours. Seventeen different bioagents are targeted in the new test, including Bacillus anthracis, E. coli, salmonella, ebola virus, and avian influenza viruses.
 

Vitros iPTH assay by Ortho Clinical Diagnostics
Vitros iPTH assay by Ortho Clinical Diagnostics

Bio-Rad Laboratories and Axis-Shield announced the FDA clearance and U.S. launch of Bio-Rad’s BioPlex 2200 Anti-CCP test for the early detection of rheumatoid arthritis. The assay, which runs on Bio-Rad’s BioPlex 2200 system, measures anti-CCP (anti-cyclic citrullinated peptide antibodies), a novel marker that has been shown to have superior specificity in the diagnosis of rheumatoid arthritis. The BioPlex 2200 Anti-CCP assay is based on Axis-Shield’s proprietary anti-CCP technology and was launched in territories outside the United States earlier in 2010.
Bio-Rad Laboratories also announced the European and Canadian launch of its BioPlex 2200 Antiphospholipid Syndrome IgG, IgM, and IgA kits for use on its BioPlex 2200 system. The BioPlex 2200 Antiphospholipid Syndrome IgG, IgM, and IgA kits are used as an aid in the diagnosis of antiphospholipid syndrome by simultaneously detecting two autoantibodies (anti-Cardiolipin and anti-Beta-2 Glycoprotein I).
FDA cleared the first test to help determine whether a pregnant woman or a person with swollen lymph nodes testing positive for toxoplasmosis developed the infection within the past four months. The Vidas TOXO IgG Avidity assay by bioMérieux can be used to rule out recent Toxoplasma gondii infection. The test works by detecting how strongly IgG avidity antibodies bind to the Toxoplasma gondii antigens in the assay. The Vidas TOXO IgG Avidity Assay test is for use in people who have been confirmed with the Toxoplasma gondii infection by using the Vidas TOXO IgG II test and who are pregnant or have swollen lymph glands.
 

DCA Vantage Analizer by Siemens Healthcare Diagnostics
DCA Vantage Analizer by Siemens Healthcare Diagnostics

Fujirebio Diagnostics announced that FDA has granted 510(k) clearance to the CYFRA 21-1 EIA assay to monitor disease progression during the course of disease and treatment of lung cancer patients. This is the first biomarker assay kit to be cleared by FDA for use in the management of patients with lung cancer. The CYFRA 21-1 assay kit is indicated for the quantitative determination of soluble cytokeratin 19 fragments in human serum. It is to be used as an aid in monitoring disease progression during the course of disease and treatment in patients with lung cancer.
Greiner Bio-One unveiled the PapilloCheck high-risk test system to augment the existing biochips product portfolio. The IVD offers analysis of 14 high-risk types of the human papillomavirus (HPV). The PapilloCheck high-risk test focuses on parallel analysis of 14 HPV types of the high-risk group (hrHPV) that are recognized as carcinogenic. In a recent clinical study, the test system based on microarray technology showed a clinically relevant sensitivity of 95.8% and a clinical specificity of 96.7% for the detection of high-grade precancerous lesions, thus meeting key requirements for fast and clear results in cervical cancer screening.
FDA allowed marketing of the first test to help diagnose people with signs and symptoms of dengue fever or dengue hemorrhagic fever. The DENV Detect IgM Capture ELISA test by Inbios detects antibodies to dengue virus in blood samples from patients who have signs and symptoms of dengue. The DENV Detect IgM Capture ELISA test is based on technology patented by CDC. This test shows cross-reaction with other closely related viruses such as those that cause West Nile disease. However, a positive test result in a patient with signs or symptoms consistent with dengue should be considered presumptive evidence of dengue.
OraSure Technologies announced the launch of the OraSure QuickFlu Rapid Flu A+B Test, an FDA-approved rapid qualitative test for the detection of influenza type A and type B, including H1N1 viral infections. The test specimen is collected with a nasal swab, nasopharyngeal swab, or nasal aspirate/wash, and results are available in as few as 10 minutes. The OraSure QuickFlu test is intended for use as an aid in the rapid differential diagnosis of influenza. OraSure QuickFlu covers a broad range of influenza subtypes, including 2009 H1N1 with proven clinical detection spanning three flu seasons from 2007 through 2009.
Orgentec Diagnostika entered the field of infectious disease diagnostics with the launch of serological tests for infectious diseases that were developed specifically for Alegria, Orgentec Diagnostika’s random-access analyzer. The new test systems can be used to test rapidly, automatically, and economically individual patient samples for specific pathogens, or to test up to 30 samples in a single instrument run. Orgentec Diagnostika offers ELISA test systems for the fully automated laboratory diagnosis of Epstein-Barr virus (EBV), measles, and the mumps virus.
Orgentec Diagnostika also developed an immunoblot test for the serological diagnosis of autoimmune liver disease. Liver-9-Line facilitates the rapid and cost-effective diagnosis of autoimmune hepatitis (type 1 and type 2 AIH) and primary biliary cirrhosis (PBC) in a single step. The test system also allows for the reliable differentiation of these autoimmune diseases from other diseases of the liver. This immunoblot is suitable for initial and differential diagnosis in cases of ambiguous symptomatology or differentiation of a positive result from screening carried out with ELISA or immunofluorescence tests.
 

i-Stat 1 Wireless handheld by Abbott
i-Stat 1 Wireless handheld by Abbott

Ortho Clinical Diagnostics (OCD) announced FDA 510(k) clearance of the Vitros intact Parathyroid Hormone (iPTH) Assay. The Vitros iPTH Assay measures intact parathyroid hormone levels and utilizes one protocol for both routine and intraoperative testing with results available in 18 minutes. The Vitros iPTH Assay is designed to be run in a fully automated, random-access format on the Vitros ECi/ECiQ and 3600 Immunodiagnostic Systems, and can also be run on the Vitros 5600 Integrated System. Equivalent analytical results are generated across all three systems.
Ortho Clinical Diagnostics also announced the availability of seven manufacturer-validated applications for the Vitros 5,1 FS and 4600 Chemistry Systems. These applications allow customers to run immunosuppressant drug assays, therapeutic drug monitoring (TDM) assays, and drugs-of-abuse test (DAT) assays from Thermo Fisher Scientific, and marks the first time the company is supporting applications for assays validated by an external third party-manufacturer to run on open channels on select Vitros instruments. The availability of these applications broadens the Vitros menu, providing customers the flexibility to meet their individual laboratory needs with easy-to-use testing options.
Randox Laboratories announced the launch of an automated laboratory assay for heart-type fatty acid binding protein (H-FABP) to be used in the diagnosis and management of patients with suspected acute coronary syndrome. This quantitative, automated assay and the positive results of several recent trials mean that H-FABP is ready to be implemented into routine clinical practice in combination with Troponin.
Roche Diagnostics introduced a complete battery of stat immunoassays for cardiac biomarker testing on the cobas 6000 analyzer series. With a nine-minute duration, the assays are faster than other cardiac immunoassay tests currently available on an integrated platform and enable labs to deliver results to doctors treating cardiac patients in about half the time of standard Roche tests. The tests complement a line of existing stat cardiac assays for Roche’s standalone platform, the cobas 4000 series. The new nine-minute stat immunoassay tests include troponin T, troponin I, CK-MB, myoglobin, and NT-proBNP, and run on the cobas e 601 analyzer.
Siemens Healthcare Diagnostics achieved CE mark registration approval to sell a fully-automated mycophenolic acid test for use on the Dimension integrated chemistry systems. With this addition, the company becomes the first to offer the consolidation of four fully-automated immunosuppressant drug (ISD) tests used by physicians to monitor organ transplant patients. The four ISD tests (mycophenolic acid, cyclosporine, tacrolimus, and sirolimus) can be run simultaneously with routine chemistry tests on the Dimension system.
 

NucliSens EasyQ MRSA by bioMerieux

Siemens Healthcare Diagnostics’ Innovance D-Dimer blood test was cleared by FDA to exclude deep vein thrombosis and pulmonary embolism in patients in which a physician’s pretest probability assessment indicates a non-high probability of embolism. The expanded use of this test helps physicians provide timely patient diagnosis in high-risk and emergency care situations. Siemens’ fully automated D-dimer blood test is performed on the company’s Sysmex and BCS family of coagulation systems, and can be used in both routine and emergency care settings.
Siemens Healthcare Diagnostics’ Advia Centaur Vitamin D Total assay was CE-marked for use on the Advia Centaur/XP Immunoassay Systems. The company is offering a fully automated Vitamin D total assay that is traceable to LC-MS/MS, considered the gold standard in vitamin D testing. In addition, the assay measures the total 25-hydroxyvitamin D (25(OH)D) level (100% D2 and D3) to ensure patients are correctly evaluated for deficiency, sufficiency, or toxicity.
Siemens Healthcare Diagnostics announced FDA clearance of twenty-one 3gAllergy allergens for use on its Immulite 2000 Immunoassay System, including approval of eight new molecular allergens never before available in the United States. Specifically, the eight new molecular allergens available include tests for major allergenic proteins derived from cat dander, dog dander, house dust mites, Aspergillus (mold), and shrimp. Currently, the Siemens 3gAllergy portfolio includes 419 specific allergens and 55 panels, with 285 allergens cleared by FDA.
Siemens Healthcare Diagnostics announced FDA clearance for its drugs-of-abuse test, the Emit II Plus 6-Acetylmorphine Assay, enabling laboratories to test selectively for heroin use in a fast and effective way. The latest addition to Siemens’ comprehensive Syva Emit Drugs-of-Abuse Testing assay menu, the Emit II Plus 6-Acetylmorphine Assay delivers high reliability, rapid screening, and zero cross reactivity to many structurally related substances to differentiate heroin use from prescription medications. The Emit II Plus 6-Acetylmorphine Assay tests specifically for 6-Acetylmorphine, and is intended for the qualitative and semi-quantitative determination of 6-AM in human urine, at a cutoff concentration of 10 ng/mL.
 

QIAamp Clinical Sample Concentrator kits by Qiagen
QIAamp Clinical Sample Concentrator kits by Qiagen

Siemens Healthcare Diagnostics’ Enhanced Liver Fibrosis (ELF) test was CE-marked for use on the Advia Centaur Immunoassay Systems. This first fully automated standardized direct biomarker panel offers clinicians a quick, reliable, minimally invasive blood test option to assess liver fibrosis with results in less than one hour. The ELF test is a simple, standardized blood test that assesses the severity of liver fibrosis by combining three direct serum biomarkers (hyaluronic acid, procollagen III amino terminal peptide, and tissue inhibitor of metalloproteinase 1) in an algorithm.
Siemens Healthcare Diagnostics’ Advia Centaur Syphilis Assay1 for the detection of antibodies against Treponema pallidum was CE-marked. Laboratories outside the United States can equip themselves with this testing tool for this serious condition and drive additional workflow and efficiency gains by combining it with other infectious disease testing on the Siemens Advia Centaur family of high-throughput, random-access immunoassay systems. The test is also currently under development for use on Advia Centaur systems in the United States.
Stanbio Laboratory announced the availability of the alpha line of CLIA-waived pregnancy tests. The alpha line of pregnancy tests offers less packaging, less waste, and more value. By bundling the individually pouched tests in quantities of 100 in a resealable bag, consumers save on costly custom-printed packaging. Individually wrapped dipstrips also prolong the life of the tests, thereby saving on wasted product and money. With its enhanced readability, 25 mIU/mL sensitivity for both urine and serum samples, small sample size requirement (four drops of urine or serum), and convenient room-temperature storage, alpha is not only economically friendly but also ecologically friendly.

Molecular Diagnostics
Abbott received approval from FDA to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus (HBV) in a patient’s blood. It is the first and only approved test capable of automating HBV viral load testing from sample extraction to final results. The test offers sensitive measurement (quantitation) of HBV in human plasma or serum from individuals chronically infected with HBV. The assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy.
Abbott received a CE mark in the European Union to market its RealTime PCR molecular diagnostic test for cytomegalovirus (CMV) DNA quantitation in human plasma or whole blood. The test is intended for use in conjunction with clinical presentation and other lab markers as an indicator to initiate therapy and as an aid in monitoring viral response to antiviral treatment. The test is not intended to be used as a screening test for CMV or as a diagnostic test to confirm the presence of CMV. The new Abbott RealTime CMV assay is performed on the Abbott m2000 system.
Abbott received approval from FDA to market its RealTime PCR test for measuring the viral load of hepatitis C (HCV). The Abbott RealTime HCV assay, developed for use on the Abbott m2000 system, is intended for use as an aid in the management of HCV-infected patients undergoing antiviral therapy. The assay measures HCV RNA levels at baseline and during treatment, and can be utilized to predict sustained and non-sustained virological response to HCV therapy.
Abbott received a CE mark for a qualitative PCR-based HIV-1 test that produces accurate results from dried blood-spot and plasma specimens. The assay is a long-awaited diagnostic tool for health officials in African nations and other resource-limited areas to detect HIV-1 infected infants at early stages and begin treatment when success is more likely. Abbott’s RealTime HIV-1 Qualitative Assay is performed on Abbott’s automated, high-throughput m2000 system. The sensitive assay detects both DNA and RNA of HIV-1.
Abbott received CE marking to market the Abbott HBV Sequencing test in the European Union. This molecular diagnostic test, which was developed to identify genomic sequences of the hepatitis B virus (HBV) and help physicians monitor HBV infections, guide treatment decisions, and predict or discover drug resistance, is the first DNA sequencing assay developed and introduced by Abbott Molecular. The CE-marked Abbott HBV Sequencing test identifies the DNA sequence of the HBV polymerase gene including all clinically relevant HBV drug resistant mutations.
BD Diagnostics announced the U.S. launch of the BD MAX for use as an open system. BD MAX is the first and only fully automated, bench-top molecular system designed to perform a broad range of molecular tests. This includes IVD assays, but also user-defined protocols and life science research applications. The BD MAX System gives clinical laboratory professionals new ability to help their institutions respond to emerging threats, such as new strains of deadly drug-resistant bacteria or respiratory illnesses.
BD Diagnostics also received FDA 510(k) clearance for the first fully automated molecular tests to detect and differentiate HSV types 1 and 2 in clinician-collected external anogenital specimens. The BD ProbeTec Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays (HSV Qx Assays) run on the BD Viper System with XTR Technology, which uses Strand Displacement Amplification technology to detect and differentiate qualitatively HSV1 and HSV2 DNA. The BD ProbeTec HSV Qx Assays offer excellent sensitivity and specificity and a significant improvement in the time-to-results over culture methods.
bioMérieux received 510(k) clearance from FDA for its NucliSens EasyQ MRSA, an automated molecular test for Methicillin Resistant Staphylococcus aureus (MRSA). The test detects seven MRSA types, covering the most prevalent strains. The test also simultaneously detects two targets, which provides added confidence to the screening results. The EasyQ system supports efficient batch processing of up to 46 MRSA screening tests in a compact space with a turnaround time of three hours. NucliSens EasyQ MRSA complements chromIDä MRSA, bioMérieux’s chromogenic media, which enables direct, color-specific visual observation of the bacterial colonies in patient samples.
Gen-Probe announced that FDA has cleared for marketing the Prodesse ProAdeno+ assay, a multiplex real-time polymerase chain reaction IVD test for the qualitative detection of human adenovirus. The ProAdeno+ assay uses real-time PCR to detect qualitatively human adenovirus DNA in nasopharyngeal specimens obtained from people exhibiting signs and symptoms of acute respiratory infection. The test is intended for use to aid in the diagnosis of human adenovirus infection. It detects, but does not differentiate among, adenovirus serotypes 1-51.
Gen-Probe announced that FDA has cleared for marketing its Aptima Trichomonas vaginalis assay on the fully automated Tigris system. The Aptima assay is the first amplified nucleic acid test specifically cleared to detect Trichomonas vaginalis. The assay may be used to test clinician-collected endocervical or vaginal swabs, urine, and specimens collected in PreservCyt solution from symptomatic or asymptomatic women.
Gen-Probe’s Panther system, a fully automated and integrated molecular testing system designed with the flexibility to handle a wide range of testing needs, has been CE-marked and is available in Europe. Key features of the Panther system include the following: fully integrated sample-in, result-out automation; primary tube sampling with random access loading for maximum flexibility and productivity; a customer-driven design, intuitive software for ease of use, and remote diagnostics capabilities; and extensive process controls that include positive sample identification, liquid level detection, reagent dispense verification, and radio frequency identification (RFID) tags on fluid containers.
Gen-Probe launched in Europe the Elucigene KRAS.BRAF kit, a sensitive, single-tube assay designed for the simultaneous quantitative detection of seven common KRAS mutations and the V600E BRAF mutation. The CE-marked assay provides information regarding mutation status that can help clinicians determine the most appropriate treatment course for patients with metastatic colorectal cancer. The Elucigene KRAS.BRAF assay can help clinicians identify patients who will not benefit from anti-EGFR therapies, thereby reducing unnecessary expense and risk of toxic exposure.
Myconostica announced the CE marking of its MycAssay Aspergillus for detection of Aspergillus DNA in serum. The CE marking is in addition to the existing CE marking for respiratory samples, which means that MycAssay Aspergillus is CE-marked for all major sample types. MycAssay Aspergillus is a molecular diagnostic test for the detection of Aspergillus spp DNA. The results provided by MycAssay Aspergillus aid physicians to make a diagnosis in patients suspected of having an infection caused by Aspergillus.
Qiagen announced the launch of several tests for cancer companion diagnostics, CE-marked with the Rotor-Gene Q thermocycler (EGFR) and the PyroMark pyrosequencing system (EGFR, NRAS, KRAS, BRAF). The tests are used in personalized healthcare for patients with cancer by identifying certain mutations in these particular genes, which then help clinicians to select and tailor the most appropriate treatment. The kits are offered as CE-marked therascreen tests in Europe as well as globally for research-use only, with the CE-marked therascreen pyrosequencing kits available in December 2010. The PCR-based kits can also be used in combination with the QIAsymphony RGQ instrument.
Qiagen also announced the launch of a range of QIAamp Clinical Sample Concentrator kits for the purification of nucleic acids from a variety of clinical samples (e.g., blood, serum, and FFPE tissue) for the analysis of genomic DNA, RNA, and viral nucleic acids. The kits are manufactured under current Good Manufacturing Practice and are in compliance with FDA Quality System Regulations 21 CFR 820 for IVD use in the United States. The batch-to-batch consistency and robustness make the kits easily integrated into diagnostic workflows. Many of the QIAamp kits can be fully automated with the QIAcube and enable simultaneous purification of up to 12 samples, which can be used in downstream diagnostic applications.
Quest Diagnostics announced that FDA has issued 510(k) clearance to the Focus Diagnostics Simplexa Flu A/B & RSV test on the 3M Integrated Cycler. The Simplexa test, developed and manufactured by Quest Diagnostics’ Focus Diagnostics business, is intended as an aid in the detection and discrimination of influenza A, influenza B, and RSV virus infections. It is the first molecular test cleared by FDA for detecting flu viruses and RSV that does not require confirmation of test results by other time-consuming methods, such as culture. In addition, the time to perform the Simplexa test following RNA extraction from a specimen takes only about an hour.
Roche Molecular Diagnostics announced that FDA has approved the Cobas AmpliPrep/Cobas TaqMan HBV Test v2.0 for use in the United States. The Roche test provides a fully automated solution for the quantitative detection of hepatitis B virus (HBV) DNA in human plasma or serum for patients on HBV antiviral therapy. The Roche Cobas AmpliPrep/Cobas TaqMan HBV Test v2.0 has been validated to quantify diverse samples from genotypes A-H and pre-core mutants across a broad linear dynamic range of 20 IU/mL to 1.7E+08 IU/mL. The assay uses a reduced sample input volume of 650 µL of either serum or plasma specimens.
Rules-Based Medicine (RBM) announced the widespread commercial availability of VeriPsych, the first and only blood-based diagnostic test to aid in confirming the diagnosis of recent onset schizophrenia. VeriPsych is a molecular diagnostic tool designed to complement the healthcare provider’s clinical impression. VeriPsych, based on the simultaneous measurement of 51 different protein and hormone biomarkers with an associated mathematical decision rule, compares the biomarker profile of a patient with suspected schizophrenia to that of patients with a confirmed diagnosis of schizophrenia. VeriPsych was developed by RBM to aid in the confirmation of the diagnosis of recent-onset schizophrenia.
Seegene announced the availability of a new respiratory multiplex molecular diagnostic test that identifies 29 respiratory viruses, including Influenza A subtypes. The Magicplex RV Panel Real-time Test enables doctors and clinicians to diagnose in less than five hours what type of pathogen is infecting a patient’s respiratory system. The Magicplex tests work in a simple two-step process: amplify the DNA/RNA sequence of the target pathogens, and read those signals using any real-time PCR instrument.

Conclusion
With new molecular products on the market, an increased demand for instruments with greater automation and connectivity, and ever-increasing opportunities for bringing point-of-care tests for various samples to market, it has been a positive year for IVD manufacturers, under the circumstances. In addition to smaller, less expensive, faster, and more accurate traditional IVDs, IVD manufacturers have continued to develop new tests that are tied to pharmaceuticals. More of these companion diagnostics for personalized medicine will continue to be introduced into the marketplace in upcoming years.
Moreover, future advances in IVDs will bring diagnostic testing even closer to the patient, and provide more-accurate, faster, and simpler testing to the marketplace. As IVD manufacturers deliver on the promise for ever-better diagnostics, IVD Technology will be here to take note of their progress.
 


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